Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT06902818
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2025-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Study Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013276', 'term': 'Stomach Ulcer'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-03-24', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum concentration of drug in plasma (Cmax)', 'timeFrame': 'pre-dose to 24 hours', 'description': 'Cmax of AD-115A'}, {'measure': 'Area under the plasma concentration-time curve during dosing interval (AUCt)', 'timeFrame': 'pre-dose to 24 hours', 'description': 'AUCt of AD-115A'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Ulcer']}, 'descriptionModule': {'briefSummary': "The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.", 'detailedDescription': 'A randomized, open-label, single-dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of AD-115A and the administration of AD-1151 for healthy subjects in fasting state'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit\n* Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit\n\nExclusion Criteria:\n\n* Individuals who have taken drugs that induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the start of the study (first dosing day), or have taken drugs that may affect this study within 10 days prior to the start of the study (first dosing day)\n* Other exclusions applied'}, 'identificationModule': {'nctId': 'NCT06902818', 'briefTitle': "The Study Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'", 'organization': {'class': 'INDUSTRY', 'fullName': 'Addpharma Inc.'}, 'officialTitle': 'A Randomized, Open-label, Single-dose, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of AD-115A and the Administration of AD-1151 for Healthy Subjects in Fasting State', 'orgStudyIdInfo': {'id': 'AD-115BE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'description': 'Period 1 : Reference Drug(Rebanex Tab), Period 2 : Test Drug(Revaprazan sulfate)', 'interventionNames': ['Drug: AD-115A, AD-1151']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'description': 'Period 1 : Test Drug(Revaprazan sulfate), Period 2 : Reference Drug(Rebanex Tab)', 'interventionNames': ['Drug: AD-115A, AD-1151']}], 'interventions': [{'name': 'AD-115A, AD-1151', 'type': 'DRUG', 'description': 'AD-115A , AD-1151 Oral Tablet', 'armGroupLabels': ['Sequence A', 'Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'H PLUS YANGJI HOSPITAL, Seoul,', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addpharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}